Apparatus for mixing and dispensing components

ABSTRACT

Apparatus and methods for mixing and dispensing components. The methods and apparatus of the invention are particularly advantageous to manually mix the components of radiopaque bone cement and inject the resulting radiopaque bone cement into skeletal structures. The manually actuated apparatus of the invention comprises: (1) a sealed mixing chamber for mixing components; (2) a dispensing chamber isolated from the sealed mixing chamber; (3) a controllable portal to open a flow path between the sealed mixing chamber and the dispensing chamber so that the dispensing chamber can receive the mixed components after they are mixed; and (4) a drive mechanism associated with the dispensing chamber to force the mixed contents from the dispensing chamber.

1. CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/438,471 filed by D. Barker et al. on May 15, 2003, andentitled “Apparatus For Mixing And Dispensing Components”. The parentSer. No. 10/438,471 application is incorporated herein by reference.

The parent application is also a continuation-in-part of applicationSer. No. 10/266,053, now U.S. Pat. No. 6,572,256, filed on Oct. 7, 2002,entitled “Multi-component, Product Handling And Delivery System”, by J.Seaton et al., which application is hereby incorporated herein byreference.

This application is a continuation-in-part of application Ser. No.10/417,553, now abandoned, filed on Apr. 17, 2003, entitled“Multi-component Handling And Delivery System”, by J. Seaton et al.,which application is hereby incorporated herein by reference.

This application also claims the benefit of U.S. Provisional ApplicationNo. 60/424,398 filed on Nov. 6, 2002, entitled “Multi-component, ProductHandling And Delivering System For Bone Void And Fracture Filling”, byL. Trebing et al. , which application is hereby incorporated herein byreference.

2. FIELD

This invention relates to methods and apparatus for mixing anddispensing at least two components. The apparatus and methods of theinvention are particularly useful to prepare bone cement and deliver thebone cement into the skeletal structure of patients, such as to injuredspinal vertebrae.

3. BACKGROUND

Numerous spinal vertebrae fractures occur each year, many in older womenas a result of osteoporosis. The pain and loss of movement accompanyingvertebral fractures severely limits activity and reduces the quality oflife. In contrast to typical bone fractures, the use of surgery to treatvertebral fractures is extremely difficult and risky. A procedure called“vertebroplasty” is a less-invasive alternative to surgery, with fewerattendant risks, and has proved extremely effective in reducing oreliminating the pain caused by spinal fractures.

Vertebroplasty involves injecting radiopaque bone cement into thedamaged vertebral body by way of a needle or cannula using x-ray(fluoroscopy) to visualize and monitor delivery. Generally,vertebroplasty is performed by radiologists, neurosurgeons, andorthopedic surgeons.

Directly prior to injection, bone cement is prepared by mixingbone-cement powder (e.g., polymethylmethacrylate “PMMA”), liquid monomer(e.g., methyl methacrylate monomer), with an x-ray contrast agent (e.g.,barium sulfate), to form a fluid mixture. The components of bone cementmust be kept separate from each other until the user is ready to mixthem to form the desired bone cement. Typically, bone-cement powder isstored in a flexible bag, pouch, bottle, or similar container, while theliquid monomer is stored for shipment and handling in a vial or tube,usually formed from glass. Bone cement sets and hardens rapidly, so thedoctors must work quickly and efficiently. A typical bone-cement mixturemay comprise 15 g polymethylmethacrylate powder, 5–10 g of methylmethacrylate monomer, and 5–8 grams of sterile barium sulfate forradiographic visualization of the cement. The radiopaque bone-cementmixture is placed in a cannula-type dispensation system, the needleportion is inserted into the patient, properly positioned, and the bonecement slowly injected into the subject vertebra using x-ray guidanceallowing the doctors to see the mixture actively infuse. When enough ofthe cement is injected into the damaged bone, as seen by x-ray, the flowis stopped and the needle is removed. However, as discussed below,stopping the flow is easier said than done. There are serious controlproblems with current cannula-type bone-cement dispensation systems.

While the procedure itself has proven very effective, problems areassociated with handling and mixing the bone cement. Bone cement hardensvery quickly, even more so upon exposure to air. Also, it is importantthat the cement delivered into the bone be virtually free of anyentrapped air bubbles or air pockets. In spite of this, bone cement istypically hand mixed in an open environment directly before theprocedure using a tongue depressor or spatula. The mixed cement is thenmanually transferred from the mixing vessel to a separate dispensingdevice, such as a syringe. Removal of the mixed cement from the mixingvessel into the caulking gun or syringe is cumbersome, time consuming,and has the potential for being mishandled, dropped or contaminated. Inany case, the resulting bone cement, since it has been exposed to air,is less fluid and harder to force through the cannula into thevertebrae. Accordingly, more pressure must be exerted by the attendingphysician on the dispensing device. The increased pressure requirementmakes control difficult and increases the likelihood that too muchcement will be injected. For example, when the x-ray indicates that thevertebrae is filled, it is difficult to stop the cement flow out of thecannula and overflow of the cement into the surrounding tissues canresult. This is unsafe for the patient since the excess cement may leakout of the vertebral body into surrounding tissue and vascularstructures. In some cases, surgery may be required to remove the excesscement.

Another disadvantage with current bone cement mixing protocols thatrequire open-air transfers stems from the toxic nature of the liquidmonomer component. Bone cement monomers, including methyl methacrylate,give off toxic vapor and are irritating to the eyes and respiratorysystem. Furthermore, acrylate monomer irritates skin and contact withminute concentrations can cause sensitization. Accordingly, handlingrequires the use of suitable gloves. So, not only must attendingclinicians worry about the deleterious effects of incorporating airbubbles into the bone cement during the cumbersome hand mixing, but alsobe concerned with health and safety issues in connection with toxicmethyl methacrylate vapors.

Currently, many clinicians begin the bone-cement mixing process by firstopening a glass vial containing the liquid monomer component. One commonmethod for opening glass vials is to snap off the top of the vial at thesmallest cross section. Unfortunately, this method risks injury tooperating-room personnel from broken glass or sharp edges. Anotherdisadvantage is that small glass shards often form during such breaking,which can fall into the cement mixture. In attempting to expedite theopening of the vial or tube holding the liquid monomer, as well asreduce any exposure to the foul odor possessed by the liquid monomer,various prior art systems have been developed for enabling the user toinsert the sealed vial or tube into an area of the vessel and then breakthe vial or tube for releasing the liquid monomer directly into the drypowder.

These prior art systems all require that the broken glass pieces orshards of the vial/tube must be separately retained and prevented fromreaching the bone cement product. In attempting to satisfy thisrequirement, substantial construction and operational difficulties haveoccurred with these prior art systems. Furthermore, in other prior artsystems, manual addition of the monomer is required, exposing the userto the foul odor of the monomer and the substantial difficultiestypically encountered in handling such products.

What is needed is a mixing and dispensing device that can mix thecomponents of bone cement in a sealed environment and provide increasedcontrol on dispensation so that the operator can readily stop thebone-cement flow when the desired amount has been dispensed.

4. SUMMARY

The invention relates to apparatus, kits, and methods for mixing anddispensing components. The methods and apparatus of the invention can beadapted to mix and dispense any components but are particularly usefulwhere the components require isolation from the surrounding atmosphere,for example, in cases where the components are adversely affected by airor because the components give off toxic vapors. The methods andapparatus of the invention are particularly appropriate where controlledand consistent mixing and dispensing are desired as well as limiting theexposure of those in proximity to any noxious fumes generated during themixing process.

In one embodiment, the invention is directed to a mixing and dispensingunit for mixing and dispensing biocompatible bone fillers. The mixingand dispensing unit of the invention is useful to mix and dispense thecomponents of biocompatible bone fillers for delivery into human oranimal patients. Examples of biocompatible fillers suitable for use inthe invention include, but are not limited to, bone cements,calcium-based fillers, bioglass, bone substitutes, and grafts. Inaddition, the mixing and dispensing unit of the invention allows facileaddition of other components before or during the mixing process, forexample, antibiotics, colorants, bone-morphogenic proteins, andopacifying agents.

The mixing and dispensing unit of the invention is useful in manymedical procedures involving the preparation and delivery ofbiocompatible bone fillers into patients (both humans and animals), forexample, vertebroplasty, tumor or bone-void filling, dentalapplications, in the treatment of a vascular necrosis, and many others.

The mixing and dispensing unit of the invention is particularly suitedto mix the components of radiopaque PMMA-based bone cement and injectthe resulting radiopaque bone cement to repair, reinforce, or replaceinjured, diseased, or insufficient bone or skeletal structures, such asto injured or diseased spinal vertebrae of human or animal patients.Preferably, delivery is accomplished by way of a tube, hose, cannula, orneedle.

The apparatus of the invention for mixing and dispensing componentscomprises: (1) a sealed mixing chamber for mixing components; (2) adispensing chamber isolated from the sealed mixing chamber; (3) acontrollable portal to open a flow path between the sealed mixingchamber and the dispensing chamber so that the dispensing chamber canreceive the mixed components after they are mixed; and (4) a drivemechanism associated with the dispensing chamber to force the mixedcontents from the dispensing chamber.

The sealed mixing chamber comprises a mixing unit; an access portal forreceiving the components; and a vacuum portal for attachment to a vacuumsupply. The mixing and dispensing unit of the invention is preferablyused in conjunction with a sealed container, which stores liquid monomerseparately. In a preferred embodiment, the sealed mixing chamber ispre-packaged with bone-cement powder and the access portal is designedto sealably receive liquid monomer from the sealed container. In orderto attain the desired transfer of the liquid monomer from the sealedvial or tube directly into the dry powder, without exposing the user tothe liquid monomer, the mixing and dispensing unit of the inventioncomprises a transfer assembly, preferably, a fluid transfer assembly.The transfer assembly of the invention is constructed for cooperatingwith the sealed container containing the liquid monomer and the sealedmixing chamber for extracting the liquid monomer from the container in aclosed loop operation and directly delivering the liquid monomer intothe sealed mixing chamber containing the dry powder. This transferoperation is achieved upon demand by the user, while preventing those inthe surrounding area from being exposed to the liquid monomer or noxiousfumes.

The sealed mixing chamber controllably communicates with the dispensingchamber by a controllable portal. In the mixing phase, the controllableportal is closed. After mixing is complete, the controllable portal isopened creating a flow path whereby the dispensing chamber receives thebone cement. The dispensing chamber comprises a dispensing portal,preferably, adapted to connect to a flexible tube, high-pressure hose,cannula, or a standard needle to deliver the mixed bone cement to apatient's vertebra. The dispensing chamber also communicates with adrive mechanism for forcing the bone cement through the dispensingportal and into the vertebroplasty delivery tube. In preferredembodiment, a single drive connection is used to mix the components andto dispense the components thereby reducing the number of manipulationsrequired for mixing and dispensing bone cement.

In an advantageous embodiment, the access portal of the sealed mixingchamber comprises a self-sealing elastic member to permit injection ofthe liquid component via a needle. In a preferred embodiment, The mixingunit comprises a helical mixing vane, and the drive mechanism fordelivery is a reversible plunger. The apparatus can include a mechanicalswitch for changing the configuration of the apparatus from a componentmixing state to a mixture dispensing state.

A preferred exemplary embodiment is manually actuable to mix anddispense liquid and powder components for bone cement without powertools or power outlets.

5. BRIEF DESCRIPTION OF THE FIGURES

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, examples, appended claims, and accompanying drawings where:

FIG. 1 is an exploded perspective view, partially broken away, depictingthe multi-component product handling and delivering system of thepresent invention;

FIG. 2 is a side elevation view, partially broken away and partially incross-section depicting the multi-component product handling anddelivering system of FIG. 1 fully assembled;

FIG. 3 is an exploded perspective view of the transfer assembly memberof the multi-component product handling and delivering system of presentinvention;

FIG. 4 is a top plan view of the transfer assembly of FIG. 3;

FIG. 5 is a cross-sectional side elevation view of the transfer assemblytaken along the line A—A of FIG. 4;

FIG. 6 is a side elevation view of the fully assembled multi-componentsystem of the present invention, partially broken away and partially incross-section;

FIG. 7 is an enlarged cross-sectional side elevation view detailing area7 of FIG. 6;

FIG. 8 is an exploded perspective view of an alternate embodiment of thetransfer assembly of the present invention;

FIG. 9 is a cross-sectional side elevation view of the transfer assemblyof FIG. 8;

FIG. 10 is a cross-sectional side elevation view of the housing formingthe transfer assembly of FIG. 8; and

FIG. 11 is a top plan view of the housing of FIG. 10.

FIG. 12 is a perspective view of a fully assembled mixing and dispensingunit of the invention;

FIGS. 13 and 14 are exploded and cross-section side elevation views of amixing and dispensing unit of the invention depicting the interrelationof component parts;

FIG. 15 is a cross-sectional view of a mixing and dispensing unit of theinvention in the mixing stage;

FIG. 15A is an enlarged view of part of FIG. 15.

FIG. 16 is a cross-sectional view of a mixing and dispensing unit of theinvention depicting the mixed components transferring to the dispensingchamber;

FIGS. 17 and 18 are cross-sectional views of a mixing and dispensingunit of the invention depicting the mixed components being dispensedfrom the dispensing chamber.

FIG. 17A is an enlarged view of part of FIG. 17.

FIGS. 19A and 19B are perspective views of an exemplary manuallyactuable apparatus in condition for mixing and dispensing, respectively;

FIG. 20 is an exploded view of the exemplary manually actuableapparatus.

6. DETAILED DESCRIPTION

By referring to FIGS. 1–11, along with the following detaileddiscussion, the construction and operation of the preferredmulti-component product handling and delivering systems of the presentinvention can best be understood. However, as will become evident fromthis disclosure, further alternate embodiments of the present inventioncan be implemented without departing from the scope of the presentinvention. Consequently, the embodiments detailed in FIGS. 1–11, and inthe following detailed disclosure, are intended for exemplary purposes,and not as a limitation of the present invention.

The present invention can be employed with any type of vessel used tointermix the two or more components. Thus, the present invention is notlimited to combining or mixing bone cements.

The components of the multi-component product handling and deliveringsystems of the present invention can be packaged and sold together as akit.

In FIGS. 1, 2, 6, and 7, multi-component product handling and deliveringsystem 20 of the present invention is fully depicted as comprisingcontainer 21, integrated bone cement handling and delivery system 22,and transfer assembly 23, preferably, a fluid transfer assembly.Container 21 is preferably a sealed container, more preferably, a sealedcontainer designed for containing corrosive chemicals, such as liquidmonomer. As used herein, “sealed” means that the container's contentsare prevented from leaking during handling and transport and areprotected from air. As shown, integrated bone cement handling anddelivery system 22 comprises cover 24 that is threadedly mounted tovessel 25.

In the preferred construction and implementation of the presentinvention, the second component of the bone cement, which comprises drypowder 26, is stored in vessel 25 of bone cement handling and deliverysystem 22, as clearly shown in FIG. 2. However, if desired, dry powder26 may be stored in any suitable container, bag, or pouch that is openedjust prior to use with the powder being added to vessel 25.

In addition to preferably shipping dry powder 26 in vessel 25 of bonecement handling and delivery system 22, the first component, whichcomprises liquid monomer 27, is contained in sealed container 21. Sealedcontainer 21 can be any suitable container adaptable to create a flowpath to the vessel by way of transfer assembly 23. For example, sealedcontainer 21 can be flexible or non-flexible plastic or polymer,preferably, glass or other chemically resistant material. In onepreferred embodiment, sealed container 21 comprises glass vial or tube30 having a single opening or portal on which cap or closure 31 ismounted.

As detailed above, cap or closure 31 of sealed container 21 comprises anintegrally formed sealing membrane, preferably, a septum to provideaccess to the interior of glass vial/tube 30. Sealing membrane 32comprises a generally conventional construction, formed of elastomericmaterial, which typically comprises elastomeric plastics, rubbers,silicones, and the like. In this way, liquid monomer 27 is sealed withinglass tube/vial 30, while providing access to the interior of tube/vial30 only upon creating a flow path, for example, by using a transferconduit, such as a suitable syringe needle.

In certain embodiments, vacuum is used to cause the sealed-containercontents to transfer into the vessel (the means for transfer). In theseembodiments, the vessel will comprise vacuum portal 35 for attachment toa vacuum supply. In other embodiments, sealed container 21 can beconstructed such that the system of the invention can operate withoutvacuum. Sealed container 21 will comprise the means to transfer thecontainer contents into vessel 25. In these embodiments, vacuum portal35 is not required. In one such embodiment, sealed container 21 is achemically resistant squeeze bottle or flexible bag so that container21's contents can be squeezed into the vessel 25. In another suchembodiment, sealed container 21 is preloaded with a pressurized gas thatfunctions to push the monomer out of container 21 upon creating a flowpath by connection to transfer assembly 23. Preferably, container 21'scontents (e.g., monomer) is preloaded along with the pressurized gas.

In addition, cover 24 of bone cement handling and delivery system 22comprises a access portal 34 and vacuum portal 35 that are mountedthereto and provide access to the interior of vessel 24. Vacuum portal35 comprises a generally conventional construction that enables a vacuumsource to be connected thereto, using any suitable vacuum connection. Inaddition, access portal 34 comprises a sealing membrane 36, preferably,a septa-like disk mounted in access portal 34 for sealing the interiorof vessel 25 from the ambient air, while also enabling access to theinterior of vessel 25 to be achieved by creating a flow path, forexample by employing a transfer conduit, such as a suitable needle orsyringe.

Finally, holder 37 is employed for maintaining sealing membrane 36 inthe precisely desired position within access portal 34. By formingholder 37 with two separate and distinct diameters, one portion ofholder 37 is inserted into access portal 34, while the second, largerdiameter portion thereof engages the outer terminating edge of accessportal 34. In this way, sealing membrane 36 is securely maintained inthe desired position within access portal 34.

The construction of transfer assembly 23 of the present invention iscompleted by providing for mating engagement thereof with cap 31 ofsealed container 21 and access portal 34 of cover 24 of handling anddelivery system 22. As fully depicted in FIGS. 1–7, in its preferredembodiment, transfer assembly 23 comprises collar portions 40 and 41,interconnected with each other along support plate 42. In addition,collar portions 40 and 41 preferably comprise generally cylindricalshapes and are coaxially aligned with each other.

In addition, collar portion 40 is constructed with an inside diameterdimensioned for co-operative, frictional engagement with cap 31 ofsealed container 21. In this way, when transfer assembly 23 is mountedto sealed container 21, transfer assembly 23 is frictionally engagedsecurely with sealed container 21, preventing any unwanted, easydislodgment of sealed container 21 from assembly 23.

Similarly, collar 41 comprises an inside dimension constructed formating, co-operative, sliding engagement with access portal 34 of cover24. In addition, by designing collar 41 with an inside dimension that isslightly greater than the outside dimension of access portal 34, secureholding engagement of transfer assembly 23 with access portal 34 isachieved whenever assembly 23 is telescopically mounted into overlyingengagement with access portal 34.

In order to complete the construction of transfer assembly 23, amechanism for providing a flow path between the vessel and the sealedcontainer, is provided. The preferred flow path is created by a transferconduit, such as dual ended piercing conduit 44 (double-tipped syringeneedle). As depicted, transfer conduit 44 comprises a support base 45, asyringe needle forming member 46 mounted to one surface of support base45 and a syringe needle forming member 47 mounted to the opposed surfaceof support base 45.

In the preferred construction, syringe needle forming members 46 and 47comprise elongated, hollow tubes mounted to support base 45 in coaxialalignment with each other, forming a continuous, elongated flow paththerebetween. In addition, each syringe needle forming member 46 and 47comprises sharp, pointed, distal ends constructed for piercing thesealing membrane 36 (any septa-like material) for gaining access to theinterior associated with the sealing membrane.

In addition, base 45 of piercing element 44 is securely mounted intransfer assembly 23, preferably affixed in support plate 42. Whenmounted in its secure position, syringe needle forming member 46 extendsinto collar portion 40, substantially centrally disposed therein. Inthis position, syringe needle forming member 46 is peripherallysurrounded by the wall forming collar portion 40 with its sharp, distalend extending toward the opening of collar 40.

Similarly, syringe needle forming member 47 is securely positioned to becentrally disposed within collar portion 40, peripherally surrounded bythe wall forming collar 41. In addition, the sharp distal end of syringeneedle forming portion 47 extends towards the open end of collar 41.

By employing this construction, the telescopic axial advance of transferassembly 23 into engagement with sealed container 21 and access portal34 of cover 24, causes syringe needle forming portions 46 and 47 topierce the sealing membranes 32 and 36 and establish a direct fluidtransfer flow path between sealed container 21 and vessel 25. In thepreferred construction, in order to eliminate any unwanted injuries, tipcover 48 is preferably mounted to syringe needle forming member 46.Since the diameter of collar portion 40 is large enough to enable afinger tip to enter its open end, the use of cover 48 prior toengagement of cover 40 onto cap 31 provides the desired protection.

In addition, in the preferred construction, collar 40 comprises radiallyextending flange 49 formed on its terminating end. By employing flange49, ease of use and control of collar 40 is provided.

By referring to FIGS. 8–11, along with the following detaileddiscussion, the construction of an alternate, preferred embodiment oftransfer assembly 23 of the present invention is provided. In thisembodiment, transfer assembly 23 comprises a housing 54 thatincorporates collar portions 55 and 56, interconnected to each other bysupport wall 57. In the preferred embodiment, collar portions 55 and 56preferably comprise generally cylindrical shapes and are verticallyaligned with each other. In addition, the central axis of each collarportion is parallel to each other and offset from each other.

As with the embodiment detailed above, collar portion 56 comprises aninside diameter constructed for mating, co-operative, sliding engagementwith access portal 34 of cover 24. In addition, by designing collarportion 56 with an inside diameter that is slightly greater than theoutside diameter of access portal 34, secure holding engagement oftransfer assembly 23 with access portal 34 is achieved whenever assembly23 is telescopically mounted into overlying engagement with accessportal 34.

In addition, collar portion 55 comprises an inside diameter dimensionedfor co-operative, frictional engagement with cap 31 of sealed container21. In addition, in this embodiment, collar portion 55 comprises aplurality of tabs 58 mounted to the inside wall of collar portion 55that extend radially inwardly therefrom. In addition, tabs 58 are formedon the inside wall of collar portion 55 in a vertical position that isslightly greater than the vertical height of cap 31 of sealed container21. Finally, in the preferred construction, tabs 58 are formed about theinside wall of collar portion 55 substantially equidistant from eachother, thereby being spaced apart a distance of about 120°.

By employing this construction, whenever sealed container 21 istelescopically inserted into collar portion 55 of transfer assembly 23,cap 31 of sealed container 21 is frictionally engaged with collarportion 55, securely locked in position by tabs 58 engaging the edge ofcap 31 and preventing telescopic removal of sealed container 21 fromcollar portion 55. In this way, once sealed container 21 has beenmounted in secure, locked engagement with transfer assembly 23,dislodgment or removal of sealed container 21 from collar 55 isprevented.

Furthermore, in this embodiment of the invention, transfer assembly 23comprises gas-flow aperture 74 comprising gas-flow conduit 61 mounted insupport wall 57 and transfer conduit 60 also mounted in support wall 57.Preferably, transfer conduit 60 and gas-flow conduit 61 are independentsyringe needles. As shown in FIGS. 8 and 9, transfer conduit 60comprises an elongated, continuous, tubular member that defines anelongated flow path and incorporates two separate and independentpiercing ends 63 and 64 mounted to support base 65. In anotherembodiment, conduit 60 is molded directly into housing 54 and, thus,support base 65 is not required.

With support base 65 of transfer conduit 60 mounted in receiving hole 69of support wall 57 of transfer assembly 23, piercing end 63 extends fromsupport wall 57 into the interior of collar portion 55, while piercingend 64 extends from support wall 57 into collar portion 56. In this way,as detailed above, whenever transfer assembly 23 is mounted to accessportal 34 of cover 24, and sealed container 21 is mounted to transferassembly 23, the monomer contained in sealed container 21 is able to betransferred through transfer conduit 60 into vessel 25.

In this embodiment of the present invention, transfer assembly 23 alsocomprises a gas-flow conduit 61 that incorporates an elongated,cylindrically shaped, hollow piercing element 66 mounted to support base67. In the preferred construction, support base 67 is mounted inreceiving hole 68 formed in support wall 57 of transfer assembly 23,with hollow piercing element 66 extending therefrom into the interior ofcollar portion 55. In addition, base 67 of gas-flow conduit 61cooperates with gas-flow aperture 74 formed in support wall 57, therebyproviding an air flow path from the ambient surroundings through hollowgas-flow conduit 61 into the interior of sealed container 21 wheneversealed container 21 is mounted in collar 55.

By employing this embodiment of the present invention, transfer assembly23 provides assurance that the monomer stored in sealed container 21 iscapable of flowing freely through transfer conduit 60 into vessel 25whenever the monomer is desired for being added into vessel 25. Byproviding a separate gas flow pathway (preferably ambient air) throughgas-flow aperture 74 and gas-flow conduit 61, gas, such as nitrogen,argon, or other inert gas or air is constantly replaced in sealedcontainer 21 as the monomer is withdrawn therefrom. In this way, thecreation of a partial vacuum is avoided and free flow of the monomer isprovided.

In the preferred construction, this embodiment of the present inventionis completed by incorporating cover 70 that is constructed for beingmounted in collar portion 55 for preventing and blocking any unwantedentry into collar portion 55, prior to the insertion of sealed container21. In this way, contact with the terminating ends of piercing elements63 and 66 is prevented and any unwanted or accidental injury is avoided.

In the preferred construction, cover 70 comprises an outwardly extendingrim 71 formed on the base thereof, which cooperates with inwardlyextending tabs 58, in order to secure cover 70 in the desired position.In addition, whenever monomer bearing sealed container 21 is ready forinsertion in collar portion 55, cover 70 is easily removed from itssecured position, thereby enabling sealed container 21 to betelescopically inserted and locked in position in collar portion 55.

6.1.1 Mixing and Dispensing Unit of the Invention

FIGS. 12–18 and the corresponding text below provide a detaileddisclosure of the construction and operation of further embodiments ofan apparatus for mixing and dispensing components termed a mixing anddispensing unit.

In operation, the mixing and dispensing unit of the invention 200corresponds to bone cement handling and delivery system 22 of FIGS. 1–11and as discussed in detail above. Transfer of liquid monomer undervacuum to mixing and dispensing unit of the invention 200 issubstantially similar to the transfer procedure described above forvessel 25. Thus, the mixing and dispensing unit of the invention ispreferably used in conjunction with sealed container 21 and fluidtransfer assembly 23, (both of FIGS. 1, 2, 6, and 7).

FIG. 12 depicts one embodiment of a fully assembled mixing anddispensing unit of the invention 200. Apparatus 200 comprises mixingchamber 295, controllable portal assembly 300, and dispensing chamber305, preferably, tube shaped, having dispensing portal 310. Preferably,dispensing portal 310 is adapted to connect to the standard needle orcannula used in vertebroplasty procedures. Controllable portal assembly300 comprises a controllable portal discussed in more detail below,which provides controlled opening of a flow path between the sealedmixing chamber 295 and dispensing chamber 305. In a preferredembodiment, mixing chamber 295 comprises cover assembly 290. Preferably,cover assembly 290 comprises top cap 315 attached to mixing-chambercover 320 by way of set screws. Mixing chamber 295 comprises accessportal 325, vacuum portal 330, and preferably comprisesengagement-pin-slot 335 for receiving engagement pin 355.

FIGS. 13 and 14 are exploded and cross-section side elevation views ofapparatus 200 depicting the interrelation of component parts in apreferred embodiment of the mixing and dispensing unit of the invention.As illustrated in FIG. 13, mixing chamber 295 defines mixing cavity 360for receiving the separate components to be mixed and dispensed.Preferably, mixing chamber 295 comprises a smaller-diameter end 365 toreceive controllable portal assembly 300. Dispensing chamber 305 isconnected to mixing chamber 295. When the controllable portal housed incontrollable portal assembly 300 is closed, sealed mixing chamber 295 isisolated from dispensing chamber 305. On the other hand, opening thecontrollable portal creates a flow path so that dispensing chamber 305can receive mixed components from mixing chamber 295 for dispensation.Preferably, dispensing chamber 305 comprises support flange 370.

As discussed above, in a preferred construction, mixing chamber 295comprises cover assembly 290 (see FIG. 12), which, in turn, comprisesend cap 315 and a mixing-chamber cover 320. In this embodiment, as shownin FIG. 13, end cap 315 comprises opening 375 aligned with vacuum portal330, and mixing-chamber cover 320 comprises opening 380 aligned withaccess portal 325.

In a preferred embodiment of cover assembly 290, mixing chamber cover320 attaches to mixing chamber 295 by threaded engagement. Mixingchamber 295 houses mixing-unit 385. Mixing unit 385 can be any assemblywell known in the art to mix components, for example, but not limitedto, mixers comprising mixing vanes, such as paddles, blades, andpropellers. Preferably, mixing unit 385 comprises cylindrical, hollowmixing shaft 390 and helical mixing vanes 395. In a more preferredembodiment, hollow mixing shaft 390 comprises a large-diameter end 400and mixing head 405.

The mixing and dispensing unit of the invention further comprises adrive mechanism to drive the mixed components from dispensing chamber305 into the desired location. The drive mechanism can be any devicewell known in the art to drive contents from a chamber. Preferably, thedrive mechanism comprises a plunger that can be driven by a rotationaldrive or simply by pushing the plunger down by hand.

The preferred drive mechanism 410 is shown in FIG. 13, which comprisesplunger shaft 415 having bore 420, which houses axially-movable plungershaft advancing member 425. Preferably, plunger advancing member 425terminates in drive head 430 constructed for rotational engagement withdrive-head engagement 351. Preferably, advancing-member 425 comprisesmale threads, and bore 420 comprises complimentary female threads.Preferably, plunger shaft 415 comprises plunger-sealing-end 435.Preferably, plunger-sealing-end 435 is constructed of a flexible,chemically resistant material and has a diameter slightly greater thanthe inner diameter of dispensing chamber 305 to ensure that all of thematerial contained within dispensing chamber 305 is axially advancedupon movement of plunger shaft 415. Preferably, drive mechanism 410 ishoused by hollow mixing shaft 390.

Rotational drive 112 (shown in FIGS. 15–18 as an arrow indicatingrotational movement) connects to rotating-means connection 350 of dropshaft 340. Rotating-means connection 350 is firmly secured to end cap315 by lock washers 352 and 353. Rotational drive 112 can be anymotorized or manually driven rotating device inducing rotation, whichare well known in the art, for example, but not limited to a drill,handle, or hand crank. In the mixing stage, rotational drive 112 rotatesmixing unit 385 by way of drop shaft 340. This is because, in the mixingstage, the lower portion 347 (see FIG. 14) of mixing unit connection 345is engaged with mixing head 405. Mixing unit connection 345 comprises alower portion 347 (see FIG. 14) having an interior configuration that isgeometrically complementary to mixing head 405 (e.g., hexagonal) so asto rotationally engage the mixing head 405 (e.g., a hexagonal shape) andan upper portion 349 (see FIG. 14) having an interior configuration thatwill not engage mixing head 405 (e.g., a smooth round shape). Mixingunit connection 345 is designed in this manner so that when drop-shaft340 is in the up position (mixing phase), mixing head 405 and drop-shaft340 are rotationally engaged by way of complementary geometries betweenthe lower portion 347 of mixing unit connection 345 and mixing head 405.On the other hand, after mixing is complete and the mixing chambercontents have been transferred to dispensing chamber 305, drop-shaft 340is dropped, whereby the smooth round upper portion 349 (FIG. 14) ofmixing unit connection 345 is adjacent to mixing head 405 and, ineffect, drop-shaft 340 is disengaged from mixing head 405. Thus,rotation of drop-shaft 340 does not rotate mixing unit 385. Thisdispensing phase is explained in more detail below.

During the mixing stage, drop shaft 340 is in the up position such thatdrive-head engagement 351 is held above and is therefore not engagedwith drive head 430. This is illustrated by FIGS. 15 and 16. At thepoint when dispensation is desired, however, by a simple mechanicaladjustment (i.e., disengaging engagement pin 355), drop shaft 340 isforced down by the action of spring 440 and washer 445 with the resultthat the lower portion 347 (FIG. 14) of mixing unit connection 345disengages from mixing head 405 and, at the same time, drive-headengagement 351 of drop shaft 340 engages with drive mechanism 410 by wayof drive head 430. Then activation of rotational drive 112 controllablyadvances plunger 415. This aspect of the embodiment is illustrated byFIGS. 17 and 18.

As mentioned above, controllable portal assembly 300 comprises amechanism for opening a flow path between mixing chamber 295 anddispensing chamber 305 after mixing of the components contained inmixing chamber 295 is complete. Such a mechanism is herein termed acontrollable portal. FIG. 13 depicts a preferred controllable portalassembly 300 comprising locking collar 450, having threads 455, and endcap 460 having locking slots 465. Controllable portal assembly 300connects to the base of mixing chamber 295. The controllable portal canbe any valve, stopcock, or other device effective to isolate thecontents of mixing chamber 295 from dispensing chamber 305 during themixing phase and also to create a flow path between mixing chamber 295and dispensing chamber 305 when transfer between mixing chamber 295 anddispensing chamber 305 is desired. A preferred embodiment of acontrollable portal is depicted in FIG. 13 as 467.

Controllable portal 467 comprises sliding tube 470 securely fixed todispensing chamber 305. Preferably, sliding tube 470 forms a tight sealwith both the mixing chamber 295 and dispensing chamber 305, forexample, by use of o-rings 475. In FIG. 13, sliding tube 470 comprises apair of windows 480 on each side and radially extending locking rods485. Sliding tube 470 further comprises plunger-locking-slot 490.Sliding tube 470 can be an integral part of dispensing chamber 305 orcan be a separate component for secure, fixed attachment to dispensingchamber 305. In a preferred embodiment, radially extending locking rods485 are positioned for cooperating, controlled, sliding engagement withthreads 455 of locking collar 450. Guide washer 495 is designed to begeometrically complementary to plunger shaft 415 so as allow plungershaft 415 to move up and down along its axis but not to rotate. Guidewasher 495 comprises tooth 500 complementary in shape toplunger-locking-slot 490.

6.1.1.1 The Mixing Phase of the Mixing and Dispensing Unit of theInvention

The components to be mixed are contained within mixing chamber 295. Oneor more of the components can be prepackaged in the mixing anddispensing unit and/or additional components can be added directlybefore mixing.

As shown in FIG. 15, during the mixing phase, sliding tube 470 ispositioned by threads 455 of locking collar 450 so that: (1) windows 480are within large-diameter end 400 of hollow mixing shaft 390; and (2)the flow path (i.e., windows 480) between mixing chamber 295 anddispensing chamber 305 is blocked. In other words, the interior ofdispensing chamber 305 is isolated from the interior of mixing chamber295, preventing the contents from entering dispensing chamber 305 duringmixing.

Further, in this mixing phase, drop shaft 340 is engaged by engagementpin 355 and therefore locked in the up position such that drive head 430is not engaged with rotating-drive-head engagement 351. And in the upposition, as discussed above, drop shaft 340 is rotationally engagedwith mixing head 405. Also, advancing member 425 is fully inserted intobore 420. Tooth 500 of guide washer 495 is engaged with locking-slot 490so that plunger shaft 415 is prevented from rotating.

In the above configuration, upon connection and operation of arotational drive 112 to rotating-means connection 350, mixing unit 385is rotated along its axis thereby mixing the components within mixingchamber 295.

6.1.1.2 Transfer of Mixed Components from Mixing Chamber to DispensingChamber of the Mixing and Dispensing Unit of the Invention

When the mixing phase is complete, the contents of mixing chamber 295are ready for transfer to dispensing chamber 305. This is accomplishedby opening controllable portal 467 to create a flow path. In a preferredembodiment, rotation of helical shaped mixing vanes 395 is used forcethe contents of mixing chamber 295 into dispensing chamber 305 by actionof mixing unit 385.

FIGS. 15 and 16 illustrate operation of controllable portal 467 to opena flow path between mixing chamber 295 and dispensing chamber 305 andusing the action of mixing unit 385 to transfer the contents. Firstlocking collar 450 is rotated whereupon locking rods 485 are guidedwithin threads 455 of locking collar 450 thereby pushing sliding tube470 and dispensing chamber 305 downward such that windows 480 are belowplunger-sealing-end 435 and a flow path between mixing chamber 295 anddispensing chamber 305 is created. Thus, the axial rotational movementof locking collar 450 causes windows 480 of sliding tube 470 to move outof engagement with the larger diameter end 400 of hollow mixing shaft390, whereby windows 480 are positioned below plunger-sealing-end 435 tocomplete the flow path.

Rotating of locking collar 450 is complete when locking rods 485 arelocked within complementary locking slots 465 of end cap 460. Theconstruction of locking rods 485 and locking collar 450 effectivelyprovide a turnbuckle construction that causes dispensing chamber 305 tomove downward.

Once dispensing chamber 305 is in the position depicted in FIG. 16,rotational drive 112 is activated to force the contents of mixingchamber 295 into dispensing chamber 305 by the helical action of mixingunit 385.

6.1.1.3 The Dispensing Phase of the Mixing and Dispensing Unit of theInvention

Once the contents are loaded into dispensing chamber 305, drop shaft 340can be dropped by releasing engagement pin 355. This causes drive-headengagement 351 of drop shaft 340 to rotationally engage with drive head430 of plunger advancing member 425. At the same time the upper portion349 (FIG. 14) of mixing unit connection 345, having a smooth interior(not shown), drops over mixing head 405 and the geometricallycomplementary lower portion 347 (FIG. 14) of connection 345 disengagesfrom mixing head 405. Accordingly, in this position, the rotation ofdrop-shaft 340 does not rotate mixing unit 385. Dispensing the contentsof dispensing chamber 305 is illustrated in FIGS. 17 and 18.

Upon activating rotational drive 112, rotating means connection 350 iscontrollably rotated. The rotational movement causes plunger advancingmember 425 to rotate. Since plunger advancing member 425 is axiallyfixed (cannot move up and down but can only rotate), plunger shaft 415and plunger-sealing-end 435 are controllably axially advancedlongitudinally through dispensing chamber 305. The longitudinal movementof plunger-sealing-end 435 in dispensing chamber 305 forces the mixedcomponents contained therein to be delivered through outlet portal 310of dispensing chamber 305. Preferably, dispensing portal 310 is adaptedto connect to the standard needle or cannula (not shown) used invertebroplasty procedures.

In addition, by controlling the rotational movement or speed ofrotating-means connection 350, the precisely desired pressure foradvancing the mixed components through dispensing chamber 305 isachieved. Furthermore, by stopping the rotational movement ofrotating-means connection 350 or reversing the direction rotating-meansconnection 350, complete control over the delivery of the mixedcomponents to the precisely desired site is achieved. In fact, byreversing the rotation of rotating-means connection 350, the plungerdirection is reversed and the contents can actually be pulled back intodispensing chamber 305. This provides much greater control thanpreviously available. In addition, in the preferred embodiment,reference indicia are marked or etched on the outer surface ofdispensing chamber 305, thereby enabling the operator to preciselymeasure the quantity of material being delivered.

In another convenient embodiment, the mixing and dispensing unit of theinvention can be calibrated such that the number of revolutions of dropshaft 340 and/or the rotational drive 112 corresponds to an amount(e.g., a weight or volume) of bone cement dispensed. In this embodiment,a clinician dispensing a biocompatible filler using the mixing anddispensing unit of the invention can dispense a predetermined amount bycompleting a pre-determined number of rotations of drop shaft 340 and/orrotational drive 112.

In view of the above disclosure, it is clear that in one embodiment, theinvention is directed to an apparatus for mixing and dispensingcomponents comprising:

(a) a sealed mixing chamber having an access portal and a vacuum portal;

(b) a dispensing chamber connected to the sealed mixing chamber, whereinthe dispensing chamber is isolated from the mixing chamber;

(c) a controllable portal for opening a flow path between the sealedmixing chamber and the dispensing chamber after the components aremixed;

(d) a drive mechanism associated with the dispensing chamber for drivingthe mixture from the dispensing chamber.

Preferably, the apparatus further comprises:

a. a sealed container for containing a first component; and

b. a transfer assembly for providing a flow path between the sealedcontainer and the sealed mixing chamber,

wherein, in operation, when the sealed container comprises the firstcomponent, connection of vacuum to the vacuum portal induces the firstcomponent to transfer into the sealed mixing chamber by way of the flowpath.

In another embodiment, the invention is directed to a method for mixingand dispensing components comprising:

(a) adding the components to an apparatus comprising:

-   -   (i) a sealed mixing chamber comprising an access portal and a        vacuum portal,    -   (ii) a dispensing chamber connected to the sealed mixing        chamber, wherein the dispensing chamber is isolated from the        mixing chamber,    -   (iii) a controllable portal,    -   (iv) a drive mechanism associated with the dispensing chamber;

(b) mixing the components in the mixing chamber to form a mixture;

(c) opening the controllable portal to create a flow path between thesealed mixing chamber and the dispensing chamber;

(d) transferring the mixture to the dispensing chamber by way of theflow path; and

(e) activating the drive mechanism to dispense the mixture from thedispensing chamber.

6.1.1.4 Illustrative Embodiment—Manually Actuable Mixer and Dispenser

Aspects of the invention may now be more clearly understood byconsideration of the following specific embodiment in the form of amanually actuable mixing and dispensing apparatus. By manually actuableis meant that both mixing of the components and dispensing of the mixedcomponents can be manually effected and controlled without the use ofpower tools. One advantage of manual actuation is that operation is notdependent on the presence of power tools or electrical outlets in asterile environment. Another is the finer level of control provided bydirect hand control.

The exemplary apparatus is similar in structure and function to theapparatus previously illustrated and described except that it providesadaptions to facilitate manual mixing and manual dispensing of the mixedcomponents. FIG. 19A is a perspective view of the assembled exemplaryapparatus 500 with a radially extending handle 543 in a first positionto facilitate manual mixing of liquid monomer and bone cement powder.The handle 543 is pivotally mounted on a handle cap 547. FIG. 19B showsthe same apparatus 500 with the handle 543 pivoted to a second positionto facilitate dispensing the mixture. The assembled apparatus 500comprises a mixing chamber 502, controllable portal assembly 507, anddispensing chamber 535, preferably tube shaped, having a dispensingportal (not visible). Preferably the dispensing portal is adapted toconnect to the standard needle or cannula used in vertebroplastyprocedures. The controllable portal assembly 507 provides controlledopening of a flowpath between the sealed mixing chamber 502 anddispensing chamber 535. Preferably mixing chamber 502 comprises a topcap 501.

FIG. 20 is an exploded view of the exemplary manually actuable mixingand dispensing apparatus 500. The apparatus is similar in operation andstructure to those already described herein. The discussion here willemphasize the modifications found advantageous for manual actuation.

It is contemplated that the apparatus 500 will be delivered with thecrank handle 543 in the open radially extended position (FIG. 19A) andthe needle transfer housing 531, 532 in place. The user will remove thecover 532 of the needle transfer housing 531 and attach a vacuum source(not shown) to the vacuum port 501A as previously described. With vacuumapplied, needles of the transfer housing pierce the cap of a monomervial and liquid monomer from the vial is drawn into the transfer housing531.

The monomer is further drawn into the mixing housing 502 which cancontain the powder polymer. The vial and the transfer housing 531 arethen removed together, the simultaneous removal assured by lockingfingers of the transfer housing locking onto the cap of the vial.

The user then mixes the monomer and powder to form bone cement byrotating the radially extended handle 543 or by rotating the handle cap547 (which acts as a knob). With the handle 543 in open position, a camsurface 543A pushes downward on a crank handle gear 548 causing the gearconfiguration to interface with a corresponding gear configuration 503Aon the end of mixing paddle 503. The manual rotational movement of thehandle or knob is thus transmitted to actuate the mixing paddle 503.

When the cement is mixed, the user rotates the controllable portalassembly 507 to open the controllable port between the mixing chamber502 and the dispensing syringe tube 535. The handle 543 is then turnedto move the mixed material through the now open port into the syringetube 535.

After the syringe tube 535 is filled, the user flips the hinged handle543 across the center of the cap 547 to lock the handle in the secondposition (FIG. 19B) into a receiving slot 547A of the cap. This changeof handle position releases the pressure of the crank handle cam 543 onthe crank handle gear 548, permitting the spring biased gear to moveupward, disengaging the gear from the paddle 503. In the secondposition, a hex cap 546 in the handle 543 engages the driveconfiguration 511A of a threaded plunger shaft 511. The paddle is thusdisengaged so that it does not move or mix during the discharge ofmaterial from the apparatus, and the handle is engaged with threadedshaft 511 for driving the mixed material out through syringe tube 535.

The user then rotates handle 543 or the knobbed crank handle cap 547 toactuate the plunger mechanism (511, 518, 533) pushing the mixed materialout the end of the syringe tube 535 and typically into a needle orcannula (not shown).

Component Structure

The needle housing 531 and needle housing cap 532 are preferably of thedesign shown and described in connection with FIG. 9. Advantageously theneedle housing 531 has a detent bump 531A in the lower tube portion tohold the housing in place during shipment and preparation. The needlehousing in place also aligns the vacuum port 501A with an opening 547Bin the crank handle cap 547 to facilitate the attachment of a vacuumline (not shown). Alternatively, the vacuum port 501A can be disposed onthe exterior of the mixing chamber or the end cap to facilitateattachment. Crank handle cap 547 houses the crank handle 543 andassembled knob components.

The crank handle is held in place by a crank handle cup comprising apivot half 541 and a clamp half 542, each secured to the crank handlecap 547. The cup (541, 542) also houses the crank handle gear 548,permitting it to slide longitudinally. The longitudinal position of thegear 548 is controlled by the cam surface 543A of the handle. The gearis loaded by spring 549 in the disengaged condition with respect to themixing paddle 503. Thus when the handle is in the first position (FIG.19A), the gear is engaged with the paddle. Pivoting the handle to thesecond position (FIG. 19B) releases the gear to its spring biaseddisengaged position.

The crank handle cup assembly (541, 542) also locks onto the top end ofthe paddle 503 to provide alignment between the paddle and the gear 548.The two halves 541, 542 are secured together as by screws 539 orsnap-fit connections (not shown). The cup could also be molded as a onepiece part.

The end cap 501 is advantageously similar to top cap 315 of FIG. 12. Itattaches the upper cap assembly to the mixing chamber 502.

The mixing paddle 503 is advantageously similar to paddle 390 of FIG.13, except that the drive end 503A has a gear configuration forinterfacing with the crank handle gear 548. It is preferred that the topof the drive end 503A have lead-in edges to assist in engagement withthe crank handle gear.

In other regards, the drive mechanisms for mixing and dispensing and themechanisms for operating the controllable port between the mixingchamber and the dispensing chamber are the same as those described forother embodiments herein.

It can now be seen that the exemplary apparatus for manually mixing anddispensing components comprises a sealed mixing chamber having an accessportal and a vacuum portal, a mixing unit in the mixing chamber to mixthe components, and a first manually actuable drive mechanism associatedwith the mixing unit to actuate mixing.

The apparatus further includes a dispensing chamber connected to thesealed mixing chamber but which is isolated from the mixing chamber. Acontrollable portal is provided for opening a flow path between thesealed mixing chamber and the dispensing chamber after the componentsare mixed. A second manually actuable drive mechanism associated withthe dispensing chamber is provided to drive the mixture from thedispensing chamber.

In advantageous forms, the mixing chamber is preloaded with bone cementpowder. The first and second drive mechanisms comprise rotationallymovable handles or knobs and preferably a common handle or knob. Amechanical switching arrangement can be provided to disengage the commonhandle or knob from the first drive mechanism. The preferred mixing unitcomprises a mixing paddle, and the preferred second drive mechanismcomprises a plunger shaft.

Although the present invention has been described in considerable detailwith reference to certain preferred embodiments and versions, otherversions and embodiments are readily implemented by those of skill inthe art. Therefore, the scope of the appended claims should not belimited to the description of the versions and embodiments expresslydisclosed herein.

It is understood that the above-described embodiments are illustrativeof only a few of the many possible specific embodiments, which canrepresent applications of the invention. Numerous and varied otherarrangements can be made by those skilled in the art without departingfrom the spirit and scope of the invention.

1. An apparatus for manually mixing and dispensing componentscomprising: a sealed mixing chamber having an access portal and a vacuumportal; a mixing unit in the mixing chamber to mix the components; adispensing chamber connected to the sealed mixing chamber, wherein thedispensing chamber is isolated from the mixing chamber; a controllableportal for opening a flow path between the sealed mixing chamber and thedispensing chamber after the components are mixed; a dispensingmechanism in the dispensing chamber adapted to expel material from thedispensing chamber; and a manually actuable crank handle, that ismovable to a first position to engage the mixing unit and disengage thedispensing mechanism, movable to a second position to engage thedispensing mechanism and disengage the mixing unit, and movable to drivethe engaged mixing unit or the engaged dispensing mechanism.
 2. Anapparatus for manually mixing and dispensing components comprising: amixing chamber having an access portal; a mixing unit in the mixingchamber; a dispensing chamber connected to the mixing chamber; adispensing mechanism in the dispensing chamber adapted to expel materialfrom the dispensing chamber; a controllable portal for opening a flowpath between the mixing chamber and the dispensing chamber after thecomponents are mixed; and a crank handle that is movable to a firstposition to engage the mixing unit and disengage the dispensingmechanism, movable to a second position to engage the dispensingmechanism and disengage the mixing unit, and movable to drive theengaged mixing unit or the engaged dispensing mechanism.
 3. Theapparatus of claim 2 wherein the mixing chamber contains bone cementpowder.
 4. The apparatus of claim 2 wherein the crank handle isrotationally movable.
 5. The apparatus of claim 2 wherein the mixingunit comprises a mixing paddle.
 6. The apparatus of claim 2 wherein thedispensing mechanism comprises a plunger shaft.
 7. The apparatus ofclaim 2 wherein the mixing chamber comprises a powder component to bemixed with a liquid component and further comprising a transfer housingto facilitate transfer of the liquid component into the mixing chamber.8. The apparatus of claim 2 wherein the crank handle is adapted to pivotabout a hinge between the first position and the second position.
 9. Theapparatus of claim 2 wherein the crank handle is adapted to rotate aboutan axis to drive the engaged mixing unit or the engaged dispensingmechanism.
 10. The apparatus of claim 2 further comprising a handle capcoupled to the mixing chamber and rotatable about an axis relative tothe mixing chamber and the dispensing chamber, wherein the crank handleis coupled to the handle cap with a hinge connection and whereinrotation of the crank handle also rotates the handle cap.
 11. A methodcomprising: introducing mixable components into a mixing chamber of acomponent mixing and dispensing apparatus, the mixing chamber having amixing unit therein; moving a crank handle coupled to the mixing chamberto a first position to engage the mixing unit and disengage a dispensingmechanism in a dispensing chamber of the apparatus; with the crankhandle in the first position, moving the crank handle to drive themixing unit; manipulating a controllable portal coupled to the mixingchamber to allow the mixable components to flow from the mixing chamberinto the dispensing chamber; moving the crank handle to a secondposition to engage the dispensing mechanism that is adapted to drive themixable components from the dispensing chamber and to disengage themixing unit; with the crank handle in the second position, moving thecrank handle to actuate the dispensing mechanism.
 12. The method ofclaim 11 wherein moving the crank handle between the first position andthe second position comprises pivoting the crank handle on a hinge. 13.The method of claim 11 wherein moving the crank handle to drive themixing unit comprises rotating the crank handle about an axis; andwherein moving the crank handle to actuate the dispensing mechanismcomprises rotating the crank handle about the axis.